Real-world early outcomes of axicabtagene ciloleucel for relapsed or refractory (R/R) follicular lymphoma (FL).

Authors

null

Caron Alyce Jacobson

Dana-Farber Cancer Institute, Boston, MA

Caron Alyce Jacobson , Michael T. Hemmer , Zhen-Huan Hu , Matthew Joshua Frank , Leslie Popplewell , Nausheen Ahmed , Yi Lin , Timothy Best , Sara Beygi , Harry H. Miao , Christine Fu , Fang Sun , Hairong Xu , Marcelo C. Pasquini

Organizations

Dana-Farber Cancer Institute, Boston, MA, Kite, a Gilead Company, Santa Monica, CA, Stanford University, Stanford, CA, City of Hope National Medical Center, Duarte, CA, The University of Kansas Medical Center, Westwood, KS, Mayo Clinic, Rochester, MN, CIBMTR (Center for International Blood and Marrow Transplant Research), Department of Medicine, Medical College of Wisconsin, Milwaukee, WI

Research Funding

Pharmaceutical/Biotech Company
Kite, a Gilead company, National Cancer Institute Grant: National Cancer Institute (CIDR [U24 CA233032])

Background: Axicabtagene ciloleucel (axi-cel) is an autologous CAR T approved for adult patients (pts) with r/r FL after ≥ 2 lines of systemic therapy. In the primary analysis of the pivotal ZUMA-5 trial, 94% of pts who received axi-cel to treat r/r FL achieved an objective response, with a 79% CR rate (Jacobson et al. 2022). Grade ≥ 3 cytokine release syndrome (CRS) and neurologic events occurred in 6% and 15% of pts, respectively. Here, we present the real-world outcomes of pts receiving axi-cel for r/r FL, including those who would have been ineligible for ZUMA-5. Methods: A total of 230 pts from 72 US centers receiving first axi-cel for r/r FL in the real-world setting between March 2021 and October 2022 were identified from the CIBMTR registry. The following pts were excluded: no consent, prior non-transplant cellular therapy, and FL grade 3b or 3a/3b unspecified. Of the 230 pts, 151 pts had post-infusion assessments and were included in the analysis of outcomes. Effectiveness outcomes were ORR, CR, DOR, PFS and OS. Adverse events included CRS, immune effector cell-associated neurotoxicity syndrome (ICANS) and prolonged cytopenia. Results: Of the 230 pts, median age was 62 years and 60% were male. Prior to infusion, 98% had an ECOG performance score of 0-1, 33% had elevated LDH, and 66% were chemo-resistant. Clinically significant comorbidities were present in 74% of the pts. Ninety-two (40%) pts would have been ineligible for ZUMA-5, mainly due to comorbidities. Pts had a median of 4 (range 1-13) lines of prior therapy including 14% who also underwent prior ASCT. Median time from leukapheresis to infusion was 28 days (IQR 26-34). 9% of pts received bridging therapy. Outcomes were analyzed among the 151 pts with follow-up (median 6.2 mo). ORR and CR rates were 93% (95% CI 88-97%) and 84% (95% CI 77-89%), respectively. Estimated PFS and OS at 6 mo were 88% (95% CI 81-92%) and 96% (95% CI 91-98%), respectively. Grade ≥ 3 CRS (ASTCT consensus) and ICANS (ASTCT consensus) occurred in 2% (95% CI 0-6%) and 13% (95% CI 8-19%) of pts, respectively. Median cumulative incidence estimates of CRS resolution was 5 days and ICANS resolution was 4 days. Among pts alive at Day 30 (n = 150), 11% experienced prolonged cytopenia (4% neutropenia, 9% thrombocytopenia). PFS and OS at 6 mo were comparable regardless of ZUMA-5 eligibility, while pts eligible for ZUMA-5 had fewer Grade ≥ 3 ICANS (10% vs 16%) and more rapid ICANS resolution (92% vs 71% resolved within 2 weeks). Pts aged ≥ 65 vs < 65 years had comparable effectiveness and safety profiles. Conclusions: This is the first report on axi-cel to treat r/r FL in real-world settings. Despite a broader pt population, early results demonstrate effectiveness and safety profiles consistent with those observed in the ZUMA-5 trial. The intent is to present findings from an updated dataset with longer follow-up at ASCO. Overall, these findings support the continued broad use of axi-cel to treat r/r FL.

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Track

Hematologic Malignancies

Sub Track

Non-Hodgkin Lymphoma

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr 7509)

DOI

10.1200/JCO.2023.41.16_suppl.7509

Abstract #

7509

Poster Bd #

60

Abstract Disclosures